The FDA’s concern over LabCorp’s marketing of its OvaSure ovarian cancer test appears to be intensifying. In a letter dated September 29, Steven Gutman, the FDA’s director of the Office of In Vitro Diagnostic Device Evaluation and Safety, warned CEO David P. King that the agency had conducted a review of the marketing and technical information available for the tests and concluded that there are "serious regulatory problems involving this device," and that regulatory action would be initiated if the premarket approval was not initiated to correct violations.

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November 2008 - Table of Contents

LIR November 2008 (full PDF issue)

Lab Stocks Level Out After October Plunge; Six Execs Offer Views on Latest Economic Developments

Hospital Referral Expense per Reportable Result Expected to Drop 11% by Year End

Survey Finds Many Starting Salaries for Pathologists Are Between $100k and $250k

Inside the Lab Industry: Lab Execs See Economy Driving More Consolidation, Will Push New Administration for Higher Reimbursement

Response Genetics Teams With NeoGenomics to Expand Cancer Testing Sales Effort

Industry Veterans Plunge Into Dental Mol Dx Market With Launch of OralDNA Labs

High Rates of Test Ordering, Reporting Errors in Physician Offices Highlight Role for Labs

Lab Stocks Dip Sharply; Down 29% Over 5 Weeks, 30% for Year

FDA Threatens LabCorp With Regulatory Action Over OvaSure Claims

Nebraska’s Pathology Services Saves $3k a Year by Paying Customer Service Reps More